To Sign or Not to Sign OPRR's General AssurancesAuthor(s): Ithiel de Sola PoolSource: IRB: Ethics and Human Research, Vol. 3, No. 10 (Dec., 1981), pp. 8-9Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564504 .

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MC) tivities. But by acknowledging the many problems in implementing my proposal, I did not mean to demon- strate that no protocol could be ap- proved. I meant rather to place a heavy burden of justification upon the re- searcher and to describe it clearly.

Culver agrees with me that the most crucial problem in getting a protocol approved would be the cost-benefit as- sessment made by the IRB. In my view, this assessment depends not only upon the development of an adequate hy- pothesis, research design and measures to protect the subjects, but also "upon whether the IRB members believe that society really wants to know the im- pact of therapist-patient sexual rela- tions in various situations." Culver claims that my "understanding of [this] is inaccurate." He writes: "To my knowledge, IRBs seldom concern themselves with that kind of social is- sue. The risk-benefit analysis which IRBs appropriately address is con-

cerned with the future research sub- jects themselves, and it is on that ground that no IRB ever could or should approve the research Riskin recommends."

Culver may be accurate in saying that IRBs "seldom concern themselves with that kind of social issue." But clearly, they were required to do so by HEW regulations in effect at the time my article appeared, which charged the IRB with determining whether "the risks are so outweighed by the sum of the benefit to the subject and the importance of the knowledge to be gained as to warrant a decision to allow the subject to accept these risks."3 Current regulations contain similar language.4

The thrust of my argument was that it is possible that knowledge gained from such a study might be important enough to make the risk-benefit ratio acceptable to a committee: "If it were shown that such relations can be bene-

ficial in identifiable situations and can be conducted without exploiting the patient, then therapeutic, utilitarian values could be weighed against moral and ethical objections. If, on the other hand, the traditional assumptions were shown to be correct, the legitimacy of the bans would be increased and they might well become more effective."

I still believe that.s REFERENCES 'Culver, Charles M.: Should we research doctor-

patient sex?, IRB: A Review of Human Sub- jects Research May 3 (No. 5): 7-8, May, 1981.

2Riskin, Leonard L.: Sexual relations between psychotherapists and their patients: Toward research or restraint. California Law Review, 67:1000-1027, 1979.

345 CFR ? 46.1012(b) (1) (1977). 446 Fed. Reg. 8389 (1981) [to be codified as 45

C.F.R. ? 46.111(a) (2)). 5Similar arguments may have been the basis for

IRB approvals of recent trials to determine the efficacy of laetrile. But see Lipsett, Mor- timer B., and Fletcher, John C., Letter to the editor, N.EJ.Med., 297: 1183-4, 1977, for a view that clinical trials on the efficacy of laetrile would be unethical.

ETTERS

a To Sign or Not to Sign OPRR's General Assurances

The Office for Protection from Re- search Risks of the Department of Health and Human Services has circu- lated to universities a sample general assurance for them to submit to HHS.

Warning: That catch-22 draft is hazardous to the health of universities.

The 21-page so-called "general" as- surance drafted by OPRR formulates procedures as detailed (and sometimes more so) as the regulations which HHS has issued for research that it funds. A university signing the sample as- surance or one like it would suffer the following consequences:

1. It would incur thousands of dollars a year of expense for staffing to handle the massive activities required by the assurance, not to mention the man days of faculty and administration time.

2. Should the university later wish to change any of the detailed procedures in the assurance, it could do so, after it has signed the assurance, only with the consent of HHS. The university thus surrenders its autonomy to HHS, which acknowledges that it has no authority by law to establish regula-

tions on human subjects for research that it does not fund. It is asking uni- versities to voluntarily place them- selves under HHS control on this matter.

3. If a funding agency other than HHS sets different conditions for its grants, a university signing the sug- gested assurance could find itself caught in conflict between the require- ments. HHS is attempting to pre-empt control of the rights of other funding agencies.

4. Since many social science faculty members and students, as a matter of First Amendment principle, will refuse to submit research on social and politi- cal matters to prior censorship by a re- view board, universities which sign assurances like that suggested by HHS will find themselves in the dilemma of either having to discipline faculty or student body members or risk losing their HHS grants or contracts. No uni- versity should choose to get into that kind of controversy.

Many major universities, such as Harvard, are declining to follow the HHS suggestions and are writing short assurances that are truly general and that do not surrender their rights to run their own affairs. Some of the ma-

jor educational organizations such as the American Council of Education are engaged in consideration of appropri- ate language for an assurance, which will both confirm the universities' de- termination to protect human subjects and retain its own autonomy.

There is no urgency. No university should sign an assurance until it has consulted its lawyers, the major educa- tional associations and its faculty in the social as well as behavioral and biomedical departments.

Ithiel de Sola Pool Massachusetts Institute of

Technology

Charles McCarthy, OPRR Director, replies: Since July 3, when the Office for Pro-

tection from Research Risks (OPRR) circulated a sample assurance to insti- tutions which held general assurances under the previous regulations, we have been in contact with more than 100 of them (approximately 20% of the institutions that received the sample assurance). The sample was intended as a guide to institutions in preparing a revised assurance. The response we have received indicates that only a few institutions have been troubled by the sample assurance. Institutions have generally reacted favorably in a ratio of at least ten that are pleased with the

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December 1981

assurance to every one that indicated disfavor. We have begun negotiating with those institutions that have ex- pressed criticism, and some that were originally critical have withdrawn their objections.

Perhaps it is worthwhile to reiterate the nature and purpose of the as- surance of compliance with the Depart- ment of Health and Human Services (HHS) regulations for the protection of human subjects involved in research (45 CFR 46).

Sec. 46.103 of the regulations states that "research covered by these regula- tions shall provide written assurance satisfactory to the Secretary that it will comply with the requirements set forth in these regulations." Sec. 46.103 also contains a series of requirements, which call for institutions to provide (1) a statement of principles under which the institution will govern itself in pro- tecting the rights and welfare of human subjects; (2) designation of one or more IRBs with provision for adequate space and staff; (3) a list of IRB members in- cluding their qualifications to serve on the IRB and their affiliation with the institution (if any); and (4) written pro- cedures governing the institution's ad- ministration of the review process.

An acceptable assurance must, there- fore, contain sufficient information to enable the Department to make a rea- sonable determination that the institu- tion has established all of the adminis- trative procedures necessary to comply with the regulations. The sample as- surance offers some examples of proce- dures that meet the requirements of Sec. 46.103. No doubt many other ad- ministrative procedures will also be ac- ceptable to the Department. The sam- ple could only provide one set of examples.

The assurance mechanism has been adopted by the Department (1) in lieu of a routine inspection system; (2) to allow institutions to follow the regula- tions by adapting existing administra- tive structures rather than creating new structures; (3) to allow institutions to develop their own policies for the protection of human research subjects so long as these include, as a minimum, conformity with HHS regulations; and (4) to serve as an educational tool since the institution is expected to circulate copies of the assurance to investigators and staff who carry out research in- volving human subjects.

In some respects the sample as- surance suggests procedures that go beyond that which is stated in the regu- lations. These procedures are included because the regulations, in establishing minimal standards for the protection

of research subjects, do not include suggestions of how to implement the regulations. Most institutions have in- dicated that they welcome suggestions that illustrate ways to implement the requirements of the regulations. The assurance suggests, but does not re- quire, some procedures that exceed minimal requirements. In all major in- stances where the assurance suggests a procedure beyond that which is re- quired, a footnote is included calling to the attention of the institution that the suggested addition is not a require- ment of the regulations.

Large portions of the regulations that directly affect investigators are re- printed in the sample assurance. This is done because experience has shown that investigators often do not read the regulations carefully. It is hoped that, at very least, they will read the as- surance, which will provide them with information necessary to adequately protect human subjects.

Dr. Pool has stated that the sample assurance would "incur thousands of dollars a year of expense." We believe that it can be executed by an institu- tion with little change in cost from past procedures, providing that the institu- tion was functioning in compliance with the former regulations. Our belief has already been confirmed by many research administrators throughout the country. In fact, most expect a sig- nificant reduction in workload.

Dr. Pool has indicated that subse- quent changes in procedure will have to be approved by HHS. Such approval will be easily obtained, provided that the changes are consistent with the regulations:'

Dr. Pool suggests that HHS is at- tempting to control the rights of other funding agencies. In fact, some 22 other agencies have already independently chosen to follow HHS regulations. Dr. Pool sems to believe that diversity is preferable to uniformity. In fact, diver- sity would rapidly increase the cost and complexity of doing business with the federal government.

Dr. Pool's First Amendment argu- ments have found little favor with the legal profession or the President's Com- mission for the Study of Ethical Prob- lems in Medicine and Biomedical and Behavioral Research. The First Amend- ment does not require institutions to abdicate control over research carried out under their auspices. Dr. Pool's arguments seem to overlook the fact that IRBs are created by and carry out review on behalf of institutions dedi- cated to research.

Dr. Pool is correct in suggesting that some institutions are developing as-

surances that differ markedly from the OPRR sample. This is permissible and expected. Each submitted assurance will be evaluated for acceptability by the Department. The standards for judgment will be (1) conformity with HHS regulations; (2) adequate protec- tions for human subjects; and (3) a statement of acceptable ethical princi- ples to be applied to all research in- volving humans under the auspices of the institution.

The Ethics of Inducing Paranoia in an Experimental Setting

In a paper entitled "Induced hearing deficit generates experimental para- noia"' Zimbardo, Anderson and Kabat perhaps unwittingly raise a question that deserves some thought.

The authors carried out an experi- ment on 18 college males. Six partici- pants, after having "completed consent and medical history forms," were hyp- notized, given a post-hynoptic sugges- tion of partial deafness without being aware of its source, and placed in an experimental social situation. Each subject was subsequently debriefed and rehypnotized with the suggestion to recall all the events experienced. The important finding was that the subjects in the experimental deafness-without- awareness group became significantly more paranoid, and experienced them- selves (and were so experienced by oth- ers) as more irritated, agitated, hostile and unfriendly than the control group.

The question to be considered here is the advisability of inducing paranoid behavior in a previously healthy indi- vidual. Aside from the other ethical questions (the subjects were not told that they would become deaf, were ex- pected to become paranoid, and that there was an unknown here in terms of possible long-term effects) there is the questionable act of inducing a state about which we do not know a great deal. In short, we do not know enough in developmental psychiatry to be con- fident that an episode of induced para- noia will have no sequelae.

I raise this question now because of our heightened awareness of develop- mental psychiatry2 and the need for more information before we expose previously healthy individuals to risks that while they are presently unknown, are not necessarily unlikely.

Melvin Lewis, M.D.

Professor of Pediatrics and Psychiatry Yale University

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